Biologicals Import Licence: Form 41 Registration and Form 10 Licence
Importing vaccines, sera and other biological products into India needs a CDSCO registration certificate (Form 41) for the overseas manufacturer and an import licence (Form 10) for the importer under the Drugs Rules, 1945. We prepare the dossier, file on the SUGAM portal and handle CDSCO queries. Laboratory work is done by the authorities and your manufacturer.
What it is
A biologicals import licence is the CDSCO permission to bring biological products, such as vaccines, sera, toxins, antigens and other Schedule C products, into India for sale or distribution. Two documents work together. The overseas manufacturer’s site and product are registered through a registration certificate in Form 41, and the Indian importer holds the import licence in Form 10.
This page is about what is different for biologicals. The general route, forms and fees for imported drugs are on our drug import licence page. Biologicals add batch-level controls and laboratory checks that ordinary tablets do not face.
Who it applies to
Importers of vaccines and sera
Companies that bring in finished vaccines, antisera, toxins or antigens for hospitals, distributors or government supply. The importer needs the licence in its own name.
Overseas manufacturers and their agents
A foreign maker needs its site and products registered in India. The Indian authorised agent files the application on its behalf with a power of attorney.
Distributors adding a biological
Take a Faridabad pharma distributor that already holds a wholesale drug licence and now wants to import a biological must still get its own registration and import licence before the first consignment. Here is the catch: a wholesale licence does not carry import rights.
Why it matters
Bring it in lawfully
Without a valid registration and licence, a consignment cannot be lawfully imported and sold.
Prove batch quality
The Rules require licensees to furnish samples from each batch for examination, and Rule 3A(1) assigns laboratory functions for sera, vaccines, toxins, antigens and similar classes to the Central Drugs Laboratory at Kasauli.
Stay covered for three years
An import licence is valid for three years under Rule 28, and a renewal applied for three months before expiry keeps it alive.
Documents required
From the overseas manufacturer
- Power of attorney in favour of the Indian agent, authenticated and apostilled or legalised
- Free sale certificate and GMP certificate
- Plant master file and product details as per Schedule D(I) and D(II)
From the Indian importer
- Wholesale drug licence in Form 20B and 21B, or equivalent
- Undertaking in Form 9
- Company incorporation papers, PAN and authorised signatory details
Product and label papers
- Labels and artwork complying with Rule 96
- Specifications, stability and batch release data
- Cold-chain and storage details
How it works
Classify the product
We confirm whether your product is a Schedule C biological, whether it is a new drug under the New Drugs and Clinical Trials Rules, 2019, and which forms apply.
Register the manufacturer
Form 40 is filed on the SUGAM portal with the fee, and CDSCO issues the registration certificate in Form 41. Rule 27A allows nine months, extendable by three months with reasons recorded.
Apply for the import licence
The importer files Form 8 with the Form 9 undertaking and the fee of ₹10,000 for one drug and ₹1,000 for each additional drug. CDSCO grants Form 10.
Import and release batches
In practice, consignments arrive through a notified port with batch documents. We coordinate sample submission, label checks and ongoing compliance, and set renewal reminders.
Timelines
Plan for nine months on Form 41
Rule 27A of the Drugs Rules allows registration within nine months, extendable by three months with recorded reasons.
Renew the licence in year three
Under Rule 28, the licence is valid for three years, and a renewal application made three months before expiry keeps it in force.
Track the certificate
CDSCO’s import FAQ gives three years for the registration certificate. Note the renewal date well before it falls due.
What happens if you import without it
Commit an offence
Importing a drug without a valid licence breaks the Drugs and Cosmetics Act, 1940, and the consignment can be held up while the matter is examined.
Strand the cargo
Vaccines and sera are temperature-sensitive, so delay at a port costs money. Finish the paperwork before you book the shipment.
Breach licence conditions
Failing to follow licence conditions, such as batch samples or label rules, puts the licence at risk of action by the licensing authority.
Frequently asked questions
What is a biologicals import licence?
It is the Form 10 import licence issued by CDSCO under the Drugs Rules, 1945 for biological products such as vaccines and sera, backed by a Form 41 registration certificate for the foreign manufacturer. Both are needed before the first commercial consignment. We prepare the dossier, file it on the SUGAM portal and answer CDSCO queries for you.
Which forms are used?
Form 40 is the manufacturer’s application and Form 41 is the registration certificate. Form 8 with a Form 9 undertaking is the importer’s application and Form 10 is the licence. Form 10A applies to drugs under Schedule X. We check the correct forms for your product at the start so the filing is right the first time.
What are the government fees?
The import licence application fee under Rule 24 is ₹10,000 for one drug and ₹1,000 for each additional drug. CDSCO’s import FAQ gives the registration certificate fee as USD 10,000 per site and USD 5,000 per drug. Fee schedules are revised, so we confirm the current figures before you pay.
How long is the licence valid?
An import licence is valid for three years under Rule 28, and a renewal application made three months before expiry keeps it in force. The registration certificate is also valid for three years under CDSCO’s import FAQ. We keep a renewal calendar for both so neither lapses mid-shipment.
Does CDL Kasauli test every biological?
Rule 3A(1) designates the Central Drugs Laboratory at Kasauli for functions on sera, vaccines, toxins, antigens, anti-toxins, surgical ligatures and bacteriophages. Licensees must also furnish samples from each batch for examination. Batch release depends on your product and licence conditions, so we plan sample timing with you in advance.
Do I need a wholesale licence before applying?
Yes. CDSCO’s import FAQ makes a wholesale drug licence a prerequisite for the importer, and the licence must cover the product category. If you do not have one, we help you get it first through your State drugs control office, since the sale licence comes from the State.
Does a new biological need extra approval?
Possibly. Under the New Drugs and Clinical Trials Rules, 2019 a new drug is treated as new for four years from approval, and import of a new drug needs separate permission in Form CT-18 granted in Form CT-19 or CT-20. We check this first so you do not file the wrong application.
What does Taxhint do and not do?
We assess the route, prepare the documents, file on the SUGAM portal, reply to CDSCO queries and track renewals. Testing is done by accredited laboratories and the authorities, and your manufacturer supplies technical data. We confirm the exact scope in writing.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
The Government fees are the Rule 24 application fee of ₹10,000 for one drug and ₹1,000 for each additional drug, plus the registration certificate fee that CDSCO’s import FAQ gives as USD 10,000 per site and USD 5,000 per drug. Please confirm current figures with us before payment.
Ready to begin?
Send us the product name, manufacturer and import plan, and we will confirm the forms, fees and sequence before you file.